Senior U.S. District Judge James S. Moody, Jr. for the Middle District of Florida entered a consent decree of permanent injunction between the U.S. and James R. Hill of Florida, doing business as Viruxo LLC, a distributor of dietary supplements. The complaint, filed by the U.S. Department of Justice on behalf of the U.S. Food and Drug Administration, sought a permanent injunction against Mr. Hill for unlawfully distributing an unapproved new drug and misbranded drug. The complaint also includes a civil fraud charge for Mr. Hill’s intent to defraud consumers by promoting his product to cure, mitigate, treat, or prevent a disease despite the absence of well-controlled clinical studies or any other credible scientific evidence to substantiate his claims.
As part of the decree, Mr. Hill represented to the court that he is not directly or indirectly engaged in distributing dietary supplements or drugs. However, if Mr. Hill intends to distribute dietary supplements or drugs, he must notify the FDA in writing at least 90 days before doing so and comply with additional requirements specified in the decree.
“Products being sold as treatments for which they have not been studied or approved defrauds consumers and can cause harm if proper treatment is delayed,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs. “When a company refuses to comply with regulations, we will take enforcement action to protect the public.”
In April 2011, the FDA and the U.S. Federal Trade Commission sent Mr. Hill a warning letter for making therapeutic claims on his website establishing that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The FDA has not approved Mr. Hill’s product for any use. In addition, the warning letter stated that Mr. Hill’s product is also a misbranded drug because its labeling failed to provide adequate directions for use.
Despite assurances that Mr. Hill was correcting violations noted in the warning letter, he continued to market his product on the Internet to consumers as a treatment for herpes.
The consent decree prohibits Mr. Hill from marketing misbranded or unapproved new drugs. Before he can resume operations, he must, among other things, hire a labeling expert, remove all representations from his website and other promotional materials that his product can cure, mitigate, treat, or prevent disease, and receive written permission from the FDA to resume operations. In addition, the decree requires Mr. Hill to notify the FDA at least 14 days before the creation of a new website, or link or reference to another website, which conveys information about his products.